volume...phone +86.10.8042.6501 sartorius stedim (shanghai) trading co., ltd. guangzhou branch...

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Container type Sampling Length Material Port Storage Quotation Connector Volume TakeOne ® Engineer-To-Order Customize TakeOne ® design to match your unique requirements This service allows the selection of a larger variety of solutions with added features, such as alternative tube materials or collection vessels, autoclavable options and more. If needed, entirely new components can be investigated with the potential to establish special supply terms with the supplier. In addition, you will be allocated a unique part number, so that the design can evolve together with your process without the hassle of changing references. The robustness of such custom solutions relies on a complete chain of engineering, qualification, application development and validation services. Contact one of our specialists to initiate a project with a dedicated team of expert engineers to help you design your TakeOne ® aseptic sampling. Configure-To-Order Standard features adjusted to your needs TakeOne ® is configured from a database of pre-qualified components with proven functionalities. This provides the flexibility needed for an application-based single use configuration whilst improving design and quotation turnaround times, manufacturing lead times and security of supply when compared with fully unique engineered custom designs. TakeOne ® Design services for aseptic sampling solutions Have a particular need and can’t find a standard solution? Sartorius Stedim Biotech offers different design services to fine-tune your sampling plan to your exact requirements. Product Information

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Page 1: Volume...Phone +86.10.8042.6501 Sartorius Stedim (Shanghai) Trading Co., Ltd. Guangzhou Branch Office Room 1105 Xing Guang Ying Jing Building No. 119, Shui Yin Road Yue Xiu District,

Container type

SamplingLength

Material

Port

Storage

QuotationConnector Volume

TakeOne®

Engineer-To-Order

Customize TakeOne® design to match your unique requirements This service allows the selection of a larger variety of solutions with added features, such as alternative tube materials or collection vessels, autoclavable options and more. If needed, entirely new components can be investigated with the potential to establish special supply terms with the supplier. In addition, you will be allocated a unique part number, so that the design can evolve together with your process without the hassle of changing references.

The robustness of such custom solutions relies on a complete chain of engineering, qualification, application development and validation services. Contact one of our specialists to initiate a project with a dedicated team of expert engineers to help you design your TakeOne® aseptic sampling.

Configure-To-Order

Standard features adjusted to your needsTakeOne® is configured from a database of pre-qualified components with proven functionalities. This provides the flexibility needed for an application-based single use configuration whilst improving design and quotation turnaround times, manufacturing lead times and security of supply when compared with fully unique engineered custom designs.

TakeOne® Design services for aseptic sampling solutions

Have a particular need and can’t find a standard solution? Sartorius Stedim Biotech offers different design services to fine-tune your sampling plan to your exact requirements.

Product Information

Page 2: Volume...Phone +86.10.8042.6501 Sartorius Stedim (Shanghai) Trading Co., Ltd. Guangzhou Branch Office Room 1105 Xing Guang Ying Jing Building No. 119, Shui Yin Road Yue Xiu District,

Designing TakeOne®

Configure your TakeOne® from our library of common components and solutions in today’s market:

Tank fitting 25 mm port (Ingold®) 1.5” Sanitary TC 2” Sanitary TC

Quantity of sampling lines 1 – 3 1 – 5 1 – 9

Tubing material Silicone (Pt) | C-Flex®

Tubing length 6” | 12” with QUICKSEAL® aseptic disconnect

Samples lndividual containersFlexboy® Bags: 50 | 150 | 250 | 500 | 1000 mLCelsius®-Pak Bags: 30 | 100 mLPETG Bottles: 30 | 60 | 125 | 250 | 500 | 1000 mLCentrifuge Tubes: 15 mL (polystyrene) | 50 mL (polypropylene)BENCHMARK® (access for needle-free syringes)

Manifolds2 – 6 gangwith 500 mL purge bag

Our experts are available to help youWhether it’s questions you may have or the development of a completely new design, Sartorius is committed to helping you successfully achieve your sampling objectives. Contact your local sales specialist to start your personalized sampling plan solution.

Ingold® is a registered trademark of Mettler-Toledo.

C-Flex® is a registered trademark of Saint-Gobain Performance Plastics Corporation

Page 3: Volume...Phone +86.10.8042.6501 Sartorius Stedim (Shanghai) Trading Co., Ltd. Guangzhou Branch Office Room 1105 Xing Guang Ying Jing Building No. 119, Shui Yin Road Yue Xiu District,

Specifications

Equipment Interface | Mounting Mechanism

25 mm port | Ingold® port up to 3 sampling lines

1.5” Sanitary TC | Close coupled up to 5 sampling lines

2” Sanitary TC | Close coupled up to 9 sampling lines

Operating Parameters

Max SIP 1 cycle @60 mins at 43 psi | 3 bar | 143.7 °C

SIP cycles after actuation 10 cycles @60 mins at 29 psi | 2 bar | 134 °C

Actuations per Line 40

Temperature Range -55 °C to 300 °C

Operating Temperature Range

-20 °C to 50 °C (configuration dependent)

Device Burst Pressure 129 psi | 8.9 bar before actuation105 psi | 7.3 bar after actuation

Recommended Max Operating Pressure

45 psi | 3.1 bar at 25 °C(do not overfill or pressurize collection vessels)

Manufacturing

Manufacturing Environment ISO 7

Sterilization Method Gamma Irradiation (25 kGy – 45 kGy)

Device Release Criteria 100% Leak-Tested (pressure decay)

Materials of contact (device only)

Septum Platinum-cured Silicone

Equipment Interface 316L Stainless Steel,electropolished (<15 µin Ra)

2 mm Cannula 316L Stainless Steel,electropolished (<15 µin Ra)

Tubing Material Silicone(Pt) or C-Flex® (374)

Regulatory Compliance

Silicone Elastomer for Closures and Tubing

USP 381 | EP 3.1.9 | 21CFR177.2600

Biocompatibility USP <88> Class VI

Bacterial Endotoxin USP <85> (<0.125 EU/mL)

Particulate Matter USP <788> (≤ 3 particles/mL >25 microns; ≤ 10 particles/mL >10 microns)

Technical Data

All items are individually packed and gamma sterilized for your convenience.

Lead Time Minimum Order Quantity

Configure-To-Order 10 weeks 5

Engineer-To-Order 12 weeks 10

Ordering Information

TakeOne® 3

Page 4: Volume...Phone +86.10.8042.6501 Sartorius Stedim (Shanghai) Trading Co., Ltd. Guangzhou Branch Office Room 1105 Xing Guang Ying Jing Building No. 119, Shui Yin Road Yue Xiu District,

Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.com

EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen

Phone +49.551.308.0

Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen

Phone +49.5665.407.0

FranceSartorius Stedim FMT S.A.S.ZI des PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex

Phone +33.442.845600

Sartorius Stedim France SASZI des PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex

Phone +33.442.845600

AustriaSartorius Stedim Austria GmbHModecenterstrasse 221030 Vienna

Phone +43.1.7965763.18

BelgiumSartorius Stedim Belgium N.V.Rue Colonel Bourg 1051030 Bruxelles

Phone +32.2.756.06.80

HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi

Phone +36.23.457.227

ItalySartorius Stedim Italy S.r.l.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)

Phone +39.055.63.40.41

NetherlandsSartorius Stedim Netherlands B.V.

Phone +31.30.60.25.080

[email protected]

PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn

Phone +48.61.647.38.40

Russian FederationLLC “Sartorius Stedim RUS”Vasilyevsky Island5th line 70, Lit. A199178 St. Petersburg

Phone +7.812.327.53.27

SpainSartorius Stedim Spain, S.A.U.Avda. de la Industria, 32Edificio PAYMA28108 Alcobendas (Madrid)

Phone +34.913.586.098

SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen

Phone +41.52.354.36.36

U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ

Phone +44.1372.737159

UkraineLLC “Sartorius Stedim RUS”Post Box 440 “B”01001 Kiev, Ukraine

Phone +380.44.411.4918

AmericasUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716

Toll-Free +1.800.368.7178

ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires

Phone +54.11.4721.0505

BrazilSartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil

Phone +55.11.4362.8900

MexicoSartorius de México, S.A. de C.V.Libramiento Norte de Tepotzotlan s/n,Colonia Barrio Tlacateco,Municipio de Tepotzotlan,Estado de México,C.P. 54605

Phone +52.55.5562.1102

[email protected]

Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175

Phone +61.3.8762.1800

ChinaSartorius Stedim (Shanghai) Trading Co., Ltd.3rd Floor, North Wing, Tower 1No. 4560 Jinke RoadZhangjiang Hi-Tech Park Pudong DistrictShanghai 201210, P.R. China

Phone +86.21.6878.2300

Sartorius Stedim (Shanghai) Trading Co., Ltd.Beijing Branch OfficeNo. 33 Yu’an RoadAirport Industrial Park Zone BShunyi District, Beijing 101300

Phone +86.10.8042.6501

Sartorius Stedim (Shanghai) Trading Co., Ltd. Guangzhou Branch OfficeRoom 1105Xing Guang Ying Jing BuildingNo. 119, Shui Yin Road Yue Xiu District, Guangzhou 510075

Phone +86.20.3836.4193

IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India

Phone +91.80.4350.5250

JapanSartorius Stedim Japan K.K.4th Fl., Daiwa Shinagawa North Bldg.8-11, Kita-Shinagawa 1-chomeShinagawa-ku, Tokyo, 140-0001 Japan

Phone +81.3.4331.4300

MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur, Malaysia

Phone +60.3.8996.0622

SingaporeSartorius Stedim Singapore Pte. Ltd.10 Science Park Rd The Alpha #02-13/14Singapore Science Park IISingapore 117684

Phone +65.6872.3966

South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400

Phone +82.31.622.5700

www.sartorius-stedim.com Spec

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